Effect of Skin Closure Techniques on Body Image and Mood in Gynecologic Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change from Baseline in Body Image Scale (BIS) Score
研究概览
简要总结
This randomized clinical trial investigates the impact of two different skin closure techniques on body image and mood in women undergoing surgery for gynecologic cancers.
Patients undergoing elective surgery with a midline abdominal incision will be randomly assigned to one of two groups: 1. Interrupted Closure Group: The surgical incision is closed using either metal clips (staples) or separate mattress sutures (individual stitches). 2. Subcuticular Sutures Group: The surgical incision is closed using continuous stitches placed under the skin surface (aesthetic stitching).
The main goal of the study is to determine whether the method of wound closure affects a patient's perception of their body image, cosmetic satisfaction, and levels of anxiety or depression.
Additionally, the study aims to prove that the subcuticular suture technique is safe and does not increase the risk of wound complications (such as infection or wound separation) compared to the other method.
Participants will be asked to complete questionnaires before surgery, and again at 1, 3 and 6 months after surgery to track changes in their feelings and satisfaction with the scar.
详细描述
Midline abdominal incisions are common in gynecologic oncology, yet the optimal skin closure technique to minimize scar-related psychological distress remains unclear. While staples offer speed, subcuticular sutures may provide superior cosmetic results. This study aims to fill the gap in the literature regarding the specific impact of these closure methods on body image and patient-reported outcomes in gynecologic cancer patients, beyond standard wound complication rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 years or older.
- •Patients scheduled for elective open gynecologic surgery for suspected or confirmed gynecologic malignancy.
- •Surgery planned to be performed via a vertical midline laparotomy incision.
- •Literate patients capable of reading, understanding, and completing the Body Image Scale (BIS) and Hospital Anxiety and Depression Scale (HADS).
- •Patients who provide written informed consent to participate in the study.
排除标准
- •History of prior radiotherapy to the abdominal or pelvic region.
- •Patients currently receiving chronic immunosuppressive therapy.
- •Body Mass Index (BMI) less than 18 kg/m^2 or greater than 40 kg/m^
- •Presence of cognitive impairment, dementia, or Alzheimer's disease.
- •Major psychiatric disorders that prevent the patient from understanding or completing the questionnaires.
- •Patients undergoing emergency surgery.
研究组 & 干预措施
Subcuticular Suture Group
Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material.
干预措施: Continuous Subcuticular Suture (Procedure)
Interrupted Closure Group
Patients in this group will undergo skin closure using interrupted techniques. The incision will be closed with either surgical staples (metal clips) or interrupted mattress sutures, depending on the standard practice.
干预措施: Interrupted Skin Closure (Procedure)
结局指标
主要结局
Change from Baseline in Body Image Scale (BIS) Score
时间窗: Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6.
The Body Image Scale (BIS) is a 10-item questionnaire designed to assess body image changes in cancer patients. Each item is scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30. Higher scores indicate higher levels of body image distress and dissatisfaction.
次要结局
- Incidence of Wound Complications(Post-operative Month 1, Month 3 and Month 6)
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score(Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6.)
研究者
Mahmut Yassa
Principal Investigator - Gynecologic Oncology Specialist
Başakşehir Çam & Sakura City Hospital